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[April 2024] FDA Draft Guidance on Drug/API Supply Discontinuance and Interruption Notification, Preparing for QMSR + Warning Letter Breakdown

We analyze the latest FDA guidance on drug supply interruptions, dissect the new QMSR final rule, and review a warning letter to a Thai pharmaceutical firm.

Welcome to Insider issue #24.

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Our pharma feature explores the FDA's issuance of draft guidance concerning the notification requirements for discontinuances or interruptions in drug and API manufacturing. Released in February 2024, this guidance clarifies obligations under Section 506C of the FD&C Act, detailing what manufacturers must report to prevent supply chain disruptions. We provide an in-depth analysis of the guidance, discussing its requirements, the role of the quality unit, and the severe implications of non-compliance.

Our device/medtech feature examines the FDA’s Quality Management System Regulation (QMSR), harmonizing the QSR with the international standard ISO 13485. This final rule, effective from February 2026, mandates a two-year transition period for manufacturers. Our coverage breaks down the major changes, outlines strategic actions for compliance, and discusses the anticipated benefits of these regulatory adjustments on global operations.

Lastly, we focus on a case study involving S&J International, a Thai firm faced with an FDA warning and import alert due to non-compliance with inspection protocols. Highlighting the January 2024 warning letter, we dissect the significant violations noted by the FDA, including inadequate quality control and poor documentation practices. This section offers practical recommendations for firms to enhance regulatory compliance and avoid similar pitfalls in highly regulated markets like the U.S.

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